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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078395
Company: RUBICON

Products on ANDA 078395

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078395

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2008	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078395s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/03/2021	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/27/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
01/28/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078395

DORZOLAMIDE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC; EQ 2% BASE
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	212639	ALEMBIC
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	090143	BAUSCH AND LOMB
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	205294	FDC LTD
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	215660	GLAND PHARMA LTD
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	202053	INDOCO
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	204778	MICRO LABS
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078395	RUBICON
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078748	SANDOZ
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078981	SANDOZ

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